FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
67457-182
11-digit product format
674570182
Labeler code
67457
Product ID
67457-182_677a4e72-7b0a-4f6c-b82e-091d93588566
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esmolol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA076474
Marketing category
ANDA
Marketing start
2007-05-29
Substance
ESMOLOL HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esmolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV05260LC8D
Rxcui1736546

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-182-00Esmolol Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION1011
67457-182-10Esmolol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-182-00ML - Milliliter67457-182e6e9201b-9f8e-45bc-be83-efc5ae87893d12015-10-02
67457-182-10ML - Milliliter67457-18233dc64ce-7de4-459d-a777-22d372c2971012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
SODIUM ACETATE ANHYDROUSINACTIVE INGREDIENTNVG71ZZ7P0ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-182ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]11Current NDC, Legacy NDC, 2 package rows20250522_94f069f9-dd52-4a69-a103-ebdb4294f088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSN94f069f9-dd52-4a69-a103-ebdb4294f08811
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD94f069f9-dd52-4a69-a103-ebdb4294f08811
1736546esmolol HCl 100 MG per 10 ML InjectionSY94f069f9-dd52-4a69-a103-ebdb4294f08811
1736546esmolol HCl 100 MG in 10 ML InjectionPSN789730fa-eaca-4986-e053-2a91aa0a53395
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD789730fa-eaca-4986-e053-2a91aa0a53395
1736546esmolol HCl 100 MG per 10 ML InjectionSY789730fa-eaca-4986-e053-2a91aa0a53395
1736546esmolol HCl 100 MG in 10 ML InjectionPSN9c1e3a64-0ef0-4071-ad6f-63ff8789b1982
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD9c1e3a64-0ef0-4071-ad6f-63ff8789b1982
1736546esmolol HCl 100 MG per 10 ML InjectionSY9c1e3a64-0ef0-4071-ad6f-63ff8789b1982
1736546esmolol HCl 100 MG in 10 ML InjectionPSN55def2c7-b354-47e6-bd25-6ecd928607951
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD55def2c7-b354-47e6-bd25-6ecd928607951
1736546esmolol HCl 100 MG per 10 ML InjectionSY55def2c7-b354-47e6-bd25-6ecd928607951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-182-006745701820010 mL in 1 VIAL10 mlHistorical
67457-182-106745701821010 VIAL in 1 CARTON (67457-182-10) / 10 mL in 1 VIAL (67457-182-00) 10 vial2007-05-290000-00-00NoNoCurrent